DIO ENAMEL COATING PEN PRO TOOTH- tricalcium phosphate, dental type silica, tocopheryl acetate paste, dentifrice 
Dio Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Tricalcium Phosphate, Dental Type Silica (Silicon Dioxide), Tocopheryl Acetate (.ALPHA.-TOCOPHEROL ACETATE)

For dental care

Keep out of reach of children

  1. Spin the lever at the bottom of the product clockwise
  2. Rub the silicon tip smoothly on the sensitive area (60 seconds)
  3. Rinse your mouth after 30 seconds once the product is absorbed)

Alright container, store at room temperature (1-30)

Sorbitol, water, etc.

For dental use only

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DIO ENAMEL COATING PEN PRO TOOTH 
tricalcium phosphate, dental type silica, tocopheryl acetate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75902-6001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICALCIUM PHOSPHATE (UNII: K4C08XP666) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION20 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE0.2 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75902-6001-15 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/01/2016
Labeler - Dio Corporation (631085206)
Establishment
NameAddressID/FEIBusiness Operations
KMPharmaceutical Co., Ltd.688679158manufacture(75902-6001)

Revised: 6/2017
Document Id: 50e23c08-72fb-6d1a-e054-00144ff8d46c
Set id: 413ab9ba-7930-0f0d-e054-00144ff8d46c
Version: 2
Effective Time: 20170601
 
Dio Corporation